BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Portex

    DI: 20351688010183 · Model: 4042-2 · ICU MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Portex
    Primary DI
    20351688010183
    Version / Model
    4042-2
    Company Name
    ICU MEDICAL, INC.
    Labeler DUNS
    118380146
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-24
    Public Version
    1
    Public Version Date
    2025-12-02
    Public Version Status
    New
    Public Device Record Key
    9e9e26ba-b095-4080-afb1-cffa2c28baf3

    Device Description

    GTIN for 4042-2, 1/EA

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JKA Tubes, vials, systems, serum separators, blood collection

    GMDN Terms

    Code Name
    57894 Blood gas syringe IVD, lithium heparin

    Identifiers

    Type ID
    Package 30351688010180
    Primary 20351688010183

    Premarket Submissions

    Submission Number Supplement Number
    K952516 000